Rotary pill dispenser and method of use

ABSTRACT

An automated medication dispenser system is disclosed. The system includes a dispenser device comprising a medication dispensing and storage module, a dispensing drive and control mechanism, and a communications interface. A third party communications host is in communication with the dispenser device, and has administration software with executable instructions for control of the dispensing drive and control mechanism to dispense medication from the medication dispensing and storage module. The communications interface is in communication with the third party communications host.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.17/078,904, filed on Oct. 23, 2020, entitled “Rotary Pill Dispenser andMethod of Use”, now U.S. Pat. No. 11,510,849; which is a continuation ofU.S. patent application Ser. No. 16/243,905, filed Jan. 9, 2019,entitled “Rotary Pill Dispenser and Method of Use”, now U.S. Pat. No.10,849,829; which is a division of U.S. patent application Ser. No.15/016,757, filed Feb. 5, 2016, entitled “Rotary Pill Dispenser andMethod of Use”, now U.S. Pat. No. 10,201,478; which claims the benefitof U.S. Provisional Patent Application No. 62/112,522, filed Feb. 5,2015, entitled “Dispenser for Determining Use of Oral Steroids”; theentire contents of each of which are hereby incorporated by referenceherein in their entireties.

FIELD

The present inventions relate to the field of medication containers anddispensers. The present inventions more specifically relate to the fieldof medication dispensers for determining use of oral steroids.

BACKGROUND

It has been shown that patients with a history of three or more burstsof oral steroids for asthma exacerbations are at increased risk offuture exacerbation. In the United States, national guidelines recommendassessing oral corticosteroid use as a marker of asthma severity andcontrol. The history of asthma exacerbations is an important componentof the risk domain of asthma control, which weighs heavily in treatmentdecisions. However, to date, determining the number of bursts of oralsteroids has been difficult and is often inaccurate.

Most physicians, including allergists, assess the frequency of priorasthma exacerbations by taking a history from the patient of the numberof times the patient has taken OCS (oral corticosteroid) bursts. Patienthistory, however, has been found to miss as many as 58% of patients whohave had three or more exacerbations in the past year. Pharmacy refillrecords can also be used to determine whether patients had three or morebursts of oral steroids and are believed to be more accurate. However,few physicians use computerized data from pharmacies to determine thenumber of OCS bursts used for asthma exacerbations.

Pharmacy data should be considered as part of the clinical assessment ofpatients with difficult-to-treat asthma. Identifying these patients canresult in additional interventions that would further reduce thepatent's risk of further exacerbations. Therefore, an improved means todetermine and use pharmacy data on the use of oral medication, such assteroids, is needed.

In addition to the foregoing, a need exists for monitoring and controlof the dispensation of medication.

SUMMARY

Accordingly, a medication container and dispenser for determining use oforal steroids and other medications is provided, as well as a method forusing same.

More particularly, an automated pill dispenser is disclosed. Theautomated pill dispenser uses a series of mechanical features, coupledwith electrical and electronic controls, communications hardware andmonitoring software to dispense controlled quantities of medication.While dispensing action may be patient driven, the device remains underthe control and monitoring of a remote administrator, and in someexamples may be controlled and monitored at all times while powered up.Remote monitoring of the device's actuation, dosage and frequency ofallowable use is monitored and controlled by an administration portal.In addition to monitoring of one or more, or all of the above features,two-way communication between the device and the administrator via acellular or other wireless signal may also be provided to allow anadministrator the ability to adjust any of the device parametersremotely and receive real-time feedback on its use.

Thus, an automated medication dispenser system is disclosed. The systemincludes a dispenser device comprising a medication dispensing andstorage module, a dispensing drive and control mechanism, and acommunications interface. A third party communications host is incommunication with the dispenser device, and has administration softwarewith executable instructions for control of the dispensing drive andcontrol mechanism to dispense medication from the medication dispensingand storage module. The communications interface is in communicationwith the third party communications host.

A medication dispenser is also disclosed. The dispenser includes adispenser housing. The housing contains a microprocessor which is linkedto a gear motor, wherein the gear motor is coupled to a pinion gear, andthe pinion gear is engaged with an internal gear. The housing alsocontains a medication dispensing plate coupled to the internal gear,wherein as the gear motor actuates; the pinion gear rotates whichrotates internal gear and the dispensing plate. The housing furthercontains a stationary medication holder, with medication stores arrangedin a circular configuration about the dispensing plate's axis ofrotation, wherein spring pressure is exerted on a base of eachmedication store forcing medication therein in the direction of thedispensing plate, such that a dose of medication is forced into a vacantaperture in the dispensing plate.

A method for control and monitoring the dosing of medication is alsoprovided. The method includes connecting a dispenser device with a thirdparty host, and once paired, automatically communicating theavailability of a dose of medication to the dispenser device. Followingloading of the dose of medication, the loading of additional doses ofmedication is restricted without additional instructions. Request forfurther instruction with physician input is sent to a third party host.Upon receipt of the instructions, dosing instructions are sent to thedispenser device. The method also includes querying whether a dispensebutton has been depressed and operating the dispenser device to delivera predetermined quantity of medication according to the dosinginstructions.

These and other features and advantages of devices, systems, and methodsaccording to this invention are described in, or are apparent from, thefollowing detailed descriptions of various examples of embodiments.

BRIEF DESCRIPTION OF DRAWINGS

Various examples of embodiments of the systems, devices, and methodsaccording to this invention will be described in detail, with referenceto the following figures, wherein:

FIG. 1 is a perspective view of a dispenser device according to one ormore examples of embodiments.

FIG. 2 is a cut-away perspective view of the dispenser device shown inFIG. 1 , with the dispenser housing removed.

FIG. 3 is an exploded view of the dispenser device according to one ormore examples of embodiments.

FIG. 4 is a perspective view of the dispensing plate and medicationholder for use with the dispenser device shown in FIG. 1 , according toone or more examples of embodiments.

FIG. 5 is a perspective view of the dispensing plate and medicationholder for use with the dispenser device shown in FIG. 1 , according toone or more examples of embodiments, identifying a pill in a cavity oraperture of the dispensing plate.

FIG. 6 is a perspective view of the dispensing plate and medicationholder for use with the dispenser device shown in FIG. 1 , according toone or more examples of embodiments, showing a pill in a cavity oraperture of the dispensing plate, and notation reflecting rotation ofthe dispensing plate.

FIG. 7 is a side elevation view of the dispenser device of FIG. 1 ,showing the device in a vertical orientation and the vertical axis (x′).

FIG. 8 is a bottom plan view of the dispenser device of FIG. 1 , withthe dispenser cap removed, showing the longitudinal cavity or aperturefor medication dispensation.

FIG. 9 is an alternative perspective view of the dispenser device ofFIG. 1 , according to one or more examples of embodiments.

FIG. 10 is a side elevation view of the dispensing plate and medicationholder for use with the dispenser device shown in FIG. 1 , according toone or more examples of embodiments, showing the cycle count cam lobe.

FIG. 11 is a perspective view of the dispensing plate and medicationholder for use with the dispenser device shown in FIG. 1 , according toone or more examples of embodiments, showing the cycle count cam lobe.

FIG. 12 is a partial side elevation view of the dispensing plate andmedication holder, battery housing, and retaining plate for use with thedispenser device shown in FIG. 1 , according to one or more examples ofembodiments, showing the cycle count cam lobe and cycle count switch.

FIG. 13 is a top plan view of the dispenser device of FIG. 1 , accordingto one or more examples of embodiments, showing the communicationinterface.

FIG. 14 is an exploded view of the communication interface of FIG. 13 ,for use with the dispenser device in one or more examples ofembodiments.

FIG. 15 is a circuit diagram of the dispenser device of FIG. 1 ,according to one or more examples of embodiments.

FIG. 16 is a logic diagram of the method and system of dispensingmedication using the dispenser device according to one or more examplesof embodiments.

It should be understood that the drawings are not necessarily to scale.In certain instances, details that are not necessary to theunderstanding of the invention or render other details difficult toperceive may have been omitted. It should be understood, of course, thatthe invention is not necessarily limited to the particular embodimentsillustrated herein.

DETAILED DESCRIPTION

Referring to the Figures, one or more examples of a dispenser, amechanism by which the dispenser operates, and a method of operation ofthe dispenser are provided. In particular, the Figures illustrate arotary pill dispenser and more specifically, an automated pill dispenser100 according to one or more examples of embodiments. Generally, thedispenser 100 is able to identify and count the number of pills 120 orother medication dispensed by the device, as well as be programmed toidentify the next dose time and amount. The medication is dispensedaccording to a mechanical or electronic metering system. As a result,the dispenser 100 shown herein is able to determine the use ofmedication (such as but not limited to oral steroids, among othermedications), and may be used to communicate and control the amount usedto a patient, physician, and others. In addition, the dispenser 100 maybe equipped to send a signal to a cell phone or other portable computingdevice. In one or more examples of embodiments, the dispenser isreplaceable. In alternative examples of embodiments, the dispenser isrefillable.

Generally, the automated pill dispenser 100, shown in FIGS. 1-3 ,consists of three major onboard sub-assemblies and two remotely locatedsupport components. Onboard components may include, but are not limitedto, a dispensing and storage module, a dispensing drive and controlmechanism, and a communications interface. Remote components mayinclude, but are not limited to a third party communications host andadministration software.

In one or more examples of embodiments as further described herein, thedevice 100 contains all of the hardware and localized control softwarerequired to perform independent dispensing operations. Functions arefurther enhanced by the communication and control application which mayreside on a third party host (such as, but not limited to, a cell phoneor other Bluetooth enabled, or near field communication enabledequipment).

According to one or more examples of embodiments, various onboardcomponents are provided, including, for example a dispensing and storagemodule, as well as a dispensing drive and control mechanism. Inparticular, referring to FIGS. 1-3 , the dispenser device 100 contains anumber of components within or on a dispenser housing 102. Secondly, theoperations of the dispenser device 100 are monitored or controlled by amicroprocessor 104 contained within the housing 102. The microprocessor104 is linked to a motor 106 which, through various linkages and gearsdiscussed in further detail hereinbelow, forms the dispensing assembly.

In particular, the microprocessor 104 is in communication with, andfacilitates or controls operation of a DC gear motor 106. While a DCgear motor 106 is specifically described for purposes of example,variations thereon accomplishing the same purposes would not depart fromthe overall scope of the present invention. A motor mounting flange 108carries the gear motor 106. The gear motor 106 is coupled to a pinion orspur gear 110. The pinion gear 110 is engaged with an internal spur gearor internal gear 112. The internal gear 112 is coupled to the pilldispensing plate 114. Consequently, as the gear motor 106 actuates,pinion gear 110 rotates, which, in turn, rotates internal gear 112 andthe dispensing plate 114. The gears described herein may be toothedgears or other gears known in the art suitable for accomplishing thepurposes provided.

Referring to FIGS. 2-6 , the stationary pill holder 118 contains apre-loaded quantity of medication, illustrated in FIG. 4 in pill form120. Medication or pills 120 are stored in a silo configuration 122.According to one or more examples of embodiments, the pill holder 118 issized to precisely accept and contain the particular pills 120 to bedispensed. Pill silos 122 are arranged in a circular configuration aboutthe dispenser plate's axis of rotation (x) which may be co-axial withthe dispenser device's vertical axis (x′) (see FIGS. 3, 7 ).

In one or more examples of embodiments, a compression spring (not shown)and spring seat 124 are located at the base one or more, and preferablyat the base of each pill silo 122. As a result, spring pressure isexerted on the base of each pill silo 122 forcing an entire column ofpills 120 in the direction of the dispensing plate 114. Spring force(assisted by gravity) is provided to insert a dose of medication (e.g.,a pill 120) into a vacant cavity or aperture 116 in the dispensing plate114. Once an aperture or cavity is populated, the resident medication orpill 120 serves as a stop which inhibits additional silos 122 fromloading into that particular aperture or cavity (see FIGS. 4-6 ).

In addition to the above described components, within the dispenserhousing 102 is a battery housing 126, which holds, for example, abattery cell 128 and a cycle count switch 160 (see FIG. 12 ). Thebattery cell 128 may be an onboard rechargeable 7.2 VDC battery pack.However, variations thereon would not depart from the overall scope ofthe present invention, such as but not limited to one or morereplaceable alkaline or lithium batteries. The battery cell 128 may beelectrically coupled to the microprocessor 104 to provide power to themicroprocessor 104. The cycle count switch 160 is also in communicationwith the microprocessor 104 to convey or count the dispensing action ofthe device. Referring to FIGS. 3 and 8 , the battery housing 126 alsomay include an aperture or hole or cavity, such as a feed chute 130extending therethrough and arranged or aligned for passage of medication(e.g., a pill 120). A retaining plate 132, also including an aperture orhole or cavity 134 which is aligned with the feed chute 130, is providedadjacent to the battery housing 126. Referring to FIGS. 3 and 9 , adispenser cap 136 may also be provided which couples to the dispenserhousing 102 to enclose the components of dispenser described herein. Inone or more examples of embodiments, the dispenser cap 136 is removable.

Referring to FIGS. 4-6 , the dispensing plate 114 contains a series ofcavities or holes or apertures 116 that may be rotated to momentarilyalign with cavities 138 in a pill holder 118 (e.g., as the dispensingplate 114 rotates). The dispensing plate 114 is rotatable to align theplate's aperture or cavity 116 with a pill silo 122. A pill or dose ofmedicine 120 in the plate's aperture 116, i.e., the populated cavity,prevents additional pills 120 from being loaded as the dispensing plate114 is rotated about the respective stationary pill silos 122. In one ormore examples of embodiments, a populated aperture or cavity 140 (e.g.,containing a resident pill 120) is rotatable into alignment with a holeor aperture 142 located in the motor mounting flange 108 (see FIGS. 3, 8). The hole or aperture geometry of the internal components of thedispenser allow the pill to fall freely through the motor mountingflange 108 and continue through the feed chute 130 located in thebattery housing 126, finally passing through an aperture 134 in theretaining plate 132 and coming to rest in a chamber located between anddefined by the retaining plate 132 and the dispenser cap 136. Referringto FIGS. 10-12 , in one or more examples of embodiments, the cycle countcam lobe 144 is provided which both engages the cycle count switch 160and may further assist the evacuation of the pill through the motormounting flange 108 as it passes through the center of the longitudinalcavity (formed by the various apertures and feed chute) during therotation cycle.

Accordingly, the foregoing describes a medication dispenser. Generally,the medication dispenser includes a dispenser housing containing amicroprocessor which is linked to a gear motor, wherein the gear motoris coupled to a pinion gear and the pinion gear is engaged with aninternal gear. A medication dispensing plate is coupled to the internalgear, wherein as the gear motor actuates; the pinion gear rotates, whichrotates internal gear and the dispensing plate. A stationary medicationholder, with medication stores arranged in a circular configurationabout the dispensing plate's axis of rotation, is also provided. Springpressure is exerted on a base of each medication store, forcingmedication therein in the direction of the dispensing plate, such that adose of medication is forced into a vacant aperture in the dispensingplate. The stationary medication holder may contain a pre-loadedquantity of medication. For example, the medication dispenser maycontain one or more pills stored in one or more silo configurations. Inone or more examples of embodiments, the dispensing plate contains aseries of apertures that, when the dispensing plate rotates, momentarilyalign with medication stores in the medication holder. A longitudinalcavity extends from the medication holder to a delivery end of themedication dispenser for passage of medication. A dispenser cap coupledto the dispenser housing. The medication dispenser may also have abattery cell within the dispenser housing. Likewise, as discussedfurther herein, the dispenser housing has a communications interface,and in some examples of embodiments, the microprocessor has a wirelesscommunications module. A cycle count switch and cam lobe are alsoprovided to count and relay or convey the actions (e.g., dispensingactions) of the dispenser.

In one or more examples of embodiments, the material(s) of the dispenserdevice 100 may be formed of a durable material. In one or more furtherexamples of embodiments, the material(s) may be formed of a sterilematerial, or a material suitable for the containment and storage ofand/or stability of medication. In one or more particular examples ofembodiments, components herein may be composed of a plastic or polymericmaterial. Combinations of materials may also be acceptable, such as butnot limited to, a motor with one or more metal or stainless steel gearsand a polymeric housing. Various sealants and joint seals known in theart may also be used without departing from the overall scope of thepresent invention.

In various examples of embodiments, one or more of the dispenser devicecomponents are formed by molding and subsequently assembled in thelinkages described herein. Likewise, in one or more examples ofembodiments, the dispensing device or pill holder may be provided withan appropriate environmental seal which maintains the integrity and/orstability of the medication contained therein.

Referring to FIGS. 1-2 and 13-14 a communication interface 146 may beprovided on or accessible through the housing 102. More specifically,the dispensing device 100 includes a face or surface containing aviewing or communication screen 148 and one or more interface buttons150, 152 in communication with the microprocessor 104. In particular,the device has a screen 148 or communication window, such as an LCDscreen 148, which may display messages to a user (e.g., a patient) andmay accept commands. Variations thereon may also be acceptable such as,but not limited to, an LED screen. In addition, the dispenser device 100has a momentary contact or switch 154, or more than one such contact orswitch. For example, a discrete momentary contact 154 may “power on” thedevice. As indicated, the device also contains one or more additionalcontrol or function buttons or switches or combinations thereof. Forexample, two color coded buttons 150, 152 may be provided directlyadjacent to the LCD screen 148 for user control of one or more devicefunctions. For instance, a “sleep” button 150 may be provided to accessor select and/or deselect a “sleep mode” power setting, while anotherbutton may be provided which is, for example, a dispense button 152.While color coded buttons are specifically described, alternativedevices may also be implemented, such as, but not limited to buttonshaving text, buttons having texture differences, pressure-sensitiveswitches, rocker switches, touch screen interface(s), and combinationsof the foregoing. Additionally, in the illustrated embodiment, therespective buttons are located beside the LCD screen 148; however,variations thereon would not depart from the overall scope of thepresent invention. The device also contains an electronic accelerometerand 3-axis gyroscope in electronic communication with the microprocessor104 (see FIG. 15 ).

FIG. 15 shows a circuit diagram of the automated pill dispenser 100according to one or more examples of embodiments. As can be seen, theautomated pill dispenser 100 has a microprocessor 104 which iselectrically coupled to the motor 106 of the automated pill dispenser100 for control thereof. Also electrically coupled to the microprocessor104 through an I/O circuit is a gyroscope 158, an accelerometer 156, acycle count button or switch 160, a dispense button 152, and a sleepmode button 150. The power button or switch 154 and battery 128 are alsoelectrically coupled to the microprocessor 104. A micro-USB charger 162is, likewise, linked to the microprocessor 104 and battery 128. Lastly,the LCD display screen 148 is electrically coupled to the microprocessor104, such that output from the microprocessor 104 is input in to the LCDscreen 148 for display. While a specific example is provided, it isunderstood that variations on the circuit arrangement of the automatedpill dispenser 100 and variations on the type and number of componentstherein may be provided without departing from the overall scope of thepresent invention.

While not specifically illustrated, in one or more examples ofembodiments, one or more switches may also be provided on or in thedispenser cap 136. In this regard, the dispensing device may alert thephysician upon the patient's opening and access to a medication (e.g.,pill 120) dispensed. Furthermore, a switch may be used to validate thatthe dispenser cap 136 is on the housing 102 before the dispensing device100 dispenses medication, such as for example, to prevent the patientfrom inadvertently dropping and/or losing the dispensed medication.

Remote monitoring of the device's actuation, dosage and frequency ofallowable use is monitored and controlled by an administration portal.In addition to monitoring of one or more, or all of the above features,two-way communication between the device and the administrator via acellular or other wireless signal may also be provided to allow anadministrator the ability to adjust any of the device parametersremotely and receive real-time feedback on its use. Accordingly, thedispensing device 100 may also include one or more remote components.That is the dispensing device 100 communicates with a third partycommunications host which houses one or more of the functions of thedispensing device. To this end, in one or more examples of embodiments,the dispenser device 100 and remote or third party host each have ameans to receive and transmit a wireless signal. In this regard, thedispenser device 100 and/or remote host are provided with a wirelessadapter or like component, and may connect to a wireless network. In oneor more examples of embodiments, the dispenser device/remote host is aBluetooth enabled device. Accordingly, the device 100 and/or remote hostmay include a transceiver chip which transmits and receives anacceptable frequency band. Alternatively or additionally, the dispenserdevice 100 and/or remote host may include a near field communicationdevice. Near field communication may be used alone or in combinationwith Bluetooth or Wi-Fi. Encryption and verification may also beprovided, regardless of the form of wireless communication. Whilewireless communication is described herein, including specific examples,variations thereon would not depart from the overall scope of thepresent invention including, for example, wired communications. One ormore of the foregoing components may be in communication with themicroprocessor for interaction with the dispensing device.

The wireless communication device permits the dispenser 100 to pair withthe third party remote host. As a result, some or all of theadministration software and other components may be housed separatelyfrom the dispensing device.

As indicated herein, dispensing medication using the dispenser device100 is accomplished and controlled in conjunction with the use ofadministration software. Generally, the dispenser device 100 is astand-alone dispensing unit with enough onboard intelligence to react toa dispensing command within the limits of preset onboard parameters. Inone or more particular examples of embodiments, all of the parametersand settings needed to control the dispensing process are stored onboardthe dispenser device 100 in the digital memory of its microprocessorcontrol. However, in alternative embodiments, less than all of theparameters and settings needed to control the dispensing process may bestored onboard the dispenser device 100, in which case they may bestored on the third party host or other remote data storage system.

It is also possible for the dispensing parameters to be altered remotelyvia a third party host. In this regard, in order for the dispensingparameters to be altered, the dispenser device 100 must be “paired” toits third party host and information sent to the host from anadministrator. Alternatively, it is contemplated that one or moredispensing parameters may be altered directly on the dispenser device100. Parameter manipulation and adjustment is controlled byadministration software and, in the case of the remote system describedabove, uploaded to the dispenser device 100 via the third party host, ascommanded by the administrator.

The parameters may remain resident on the dispenser device 100 untilsuch time(s) as a command to update data is received from theadministrator via the third party host. Alternatively, parameters may bedelivered in real time. In the event of a loss of signal between thedispenser device 100 and the third party host, the device may act as astand-alone unit dispensing within the limits of the parameters lastuploaded and stored on the device.

In one or more examples of embodiments, a microprocessor 104 hasinstructions for how many cycles are to be dispensed. The microprocessor104 may perform this determination by use of initial dispensing data.Accordingly, in one or more examples of embodiments, the dispenserdevice 100 has initial dispensing data. The initial dispensing datacomprises a data packet. The data packet consists of integers thatpopulate preconfigured set point fields and form the basis of thedispensing criteria. A variety of dispensing criteria may be used andmay be contemplated by one of skill in the art in a manner suitable forthe intended purposes. As a non-limiting example, the device may bepreconfigured to consider one (1) cycle to constitute one (1) pilldispensed a total of one (1) time. The dispensing criteria, accordingly,may contain the number of cycles required per dispensing event, as wellas the number of times an event can be executed. Alternative oradditional criteria, such as a lapsed time period, and the like, may beused without departing from the overall scope of the present inventions.

Accordingly, the microprocessor 104 monitors the total number of cycles(e.g. using the cycle count switch) and decrements the count from avalue stored in memory. The count may be associated with the amount ofmedicine, the amount of doses, amount of doses available or remaining,and other suitable parameters. As the contents of the device (e.g.,medicine 120) are depleted, the count reduces. Set points may beprovided or available or set to trigger one or more messages back to thethird party host to alert the host of the incident of achieving a setpoint—e.g., a low set point achieved—as well as count totally depleted,or other incidents or factors of concern. In one or more examples ofembodiments, the count may be reset or increased (for example, by aphysician or pharmacist) if the dispenser device 100 is refillable.

The execution of each event is also controlled by the data packet. Thenumber of events deployable within a given time frame may be controlled,as well as the total number of events allowable between reloading of thedata from the third party host. As indicated, in one or more examples ofembodiments, if the device is not paired with the third party host, atotal number of events may be allowed or limited in keeping with thepre-loaded criteria or parameters. Once the total number of dispensingevents has been deployed, the device may await instruction from thethird party host. If pairing is not re-established and a new data packetuploaded, the device may enter a low power hibernation mode untilre-paired or until the batteries are depleted. Charging and rechargingof the device will maintain the hibernation mode indefinitely.

In one or more examples of embodiments, the dispenser device 100 hasthree power states, although fewer or more than three power states mayalso be acceptable for the intended purposes. For instance, the powerstates include “power on” (and “off”), “sleep mode” and “low powerhibernation”. Power on is the operational power mode. Sleep mode is astandby mode designed to conserve battery power, but maintain a fullstate of readiness. Low power hibernation is an ultra-low powercondition designed to provide sufficient power to maintain the device'sability to receive a wireless signal. Low power hibernation should notbe confused with sleep mode-which retains a state of readiness. Forexample, the device may be programmed to enter sleep mode if leftuninterrupted for a period of time (for example, but not limited to,three minutes or longer). Awakening from sleep mode is accomplished bysimply rotating the device about its vertical axis (x′) or by depressinga button 150 or 152 located on the control interface 146.

As indicated, in one or more examples of embodiments the dispenserdevice 100 and third party host, the system of dispensing medication,and/or method may be implemented by a computer system or in combinationwith a computer system. The computer system and/or dispensing device maybe or include a processor. The computer systems may be portableelectronic devices for use with the methods and various componentsdescribed herein and may be programmable computers which may be specialpurpose computers or general purpose computers that execute the systemaccording to the relevant instructions. The computer system or portableelectronic device can be an embedded system, a personal computer,notebook computer, server computer, mainframe, networked computer,workstation, handheld computer, as well as now known or future developedmobile devices, such as for example, a personal digital assistant, cellphone, smartphone, tablet computer, and the like. Other computer systemconfigurations are also contemplated for use with the communicationsystem including, but not limited to, multiprocessor systems,microprocessor-based or programmable electronics, network personalcomputers, minicomputers, smart watches, and the like. Preferably, thecomputing system chosen includes a processor suitable in size toefficiently operate one or more of the various systems or functions orattributes of the system and devices described.

The system or portions thereof may also be linked to a distributedcomputing environment, where tasks are performed by remote processingdevices that are linked through a communication network(s). To this end,the system may be configured or linked to multiple computers in anetwork including, but not limited to, a local area network, wide areanetwork, wireless network, and the Internet. Therefore, information,content, and data may be transferred within the network or system bywireless means, by hardwire connection, or combinations thereof.Accordingly, the servers described herein communicate according to nowknown or future developed pathways including, but not limited to, wired,wireless, and fiber-optic channels.

Data may be sent or submitted via the Internet, wireless, andfiber-optic communication network(s), or created or stored on aparticular device. In one or more examples of embodiments, data, such asbut not limited to, instructions, parameters, analytic or usage data maybe stored. In one or more examples of embodiments, data may be storedremotely or may be stored locally on a user's device. In one example,data may be stored locally in files, such as but not limited to, datastored by an app. However, data may also be stored remotely andretrieved. Locally created content or data may also be used and stored.

Data may be stored and transmitted by and within the system in anysuitable form. Any source code or other language suitable foraccomplishing the desired functions described herein may be acceptablefor use.

Furthermore, the computer or computers or portable electronic devicesmay be operatively or functionally connected to one or more mass storagedevices, such as but not limited to, a database. The memory storage canbe volatile or non-volatile, and can include removable storage media.Cloud-based storage may also be acceptable. The system may also includecomputer-readable media which may include any computer-readable media ormedium that may be used to carry or store desired program code that maybe accessed by a computer. The invention can also be embodied ascomputer-readable code on a computer-readable medium. To this end, thecomputer-readable medium may be any data storage device that can storedata which can be thereafter read by a computer system. Examples ofcomputer-readable medium include read-only memory, random-access memory,CD-ROM, CD-R, CD-RW, magnetic tapes, flash drives, as well as otheroptical data storage devices. The computer-readable medium can also bedistributed over a network-coupled computer system so that thecomputer-readable code is stored and executed in a distributed fashion.

The portable electronic device, software system and communicationinterface further operate and integrate with a user's personal computer.In one or more examples of embodiments, a user's personal computer mayact or operate as a “server” storing one or more data files (e.g.,parameters) for use by the software system and communication interface.The personal computer may also utilize an Internet-connected website,provided to manage one or more functions of the software system andcommunication interface operated by the portable electronic device. Inother words, the portable electronic device, software application,communication interface, personal computer, and website may beintegrated for use.

The computer or portable electronic device or the communicationinterface (e.g., LCD screen 148) can also include a display, provisionfor data input and output, etc. For example, these devices include agraphical user interface (GUI) or a communication means by whichcommands may be entered and content may be displayed or communicated.The computer or portable electronic device includes a user interfacethat allows navigation of objects. The computer or portable electronicdevice implements or includes an application that enables a user todisplay and interact with communications.

Aspects of the method described herein are implemented on a softwaresystem running on a computer system. To this end, the methods and systemmay be implemented in, or in association with, a general purposesoftware package or a specific purpose software package.

The software system described herein may include a mixture of differentsource codes. The system or method herein may be operated bycomputer-executable instructions, such as but not limited to, programmodules, executable on a computer. Examples of program modules include,but are not limited to, routines, programs, objects, components, datastructures, and the like which perform particular tasks or implementparticular instructions. The software system may also be operable forsupporting the transfer of information within a network.

In one or more examples of embodiments, the system described herein,and/or portions thereof, may be implemented in a web-based platform orwebsite platform or a device application (“app”) platform, or acombination or integration of web and mobile app or application platformor structure. The software application may be, for example, a mobiledevice app having an integrated website. In one particular example of amobile application, the system may operate within a closed-loop serversystem. In this example, the application and a linked website integratewith closed-loop servers using supporting source code. Any source codecapable of supporting the functions described herein may be suitable forthe purposes provided. The servers may facilitate the storage of data orcontent (e.g., parameters described herein), and synchronize theapplication and web content libraries, in/out message boxes, pushnotifications, software updates, and other data and/or features, such asuser usage analytics and the like. The portable electronic devices orInternet-connected devices also communicate with the servers to exchangethe referenced data, including the transfer of data associated with eachmessage created by the system.

An integrated file system may also be provided which allows users oradministrators to manage, select, create, and import content or data.Various examples of file structures and categories are acceptable foruse with the integrated file system.

Referring to FIG. 16 , a logic diagram illustrating the operation of theadministration software is provided. After a patient receives a fullyloaded (e.g., loaded with medication) dispenser device, the deviceinitially connects or pairs with Bluetooth. Once paired, the softwarefrom the third party host communicates the availability of the firstdose to the dispenser device. In one or more examples of embodiments,the software may count the total number of doses of medication availableand dispensed based upon a predetermined load and analysis of theactions of the dispensing device. A message is also displayed on thecommunication interface identifying the availability of a dose. When apatient lifts the dispenser device (e.g., when a patient is experiencinga new exacerbation), the accelerometer activates the dispenser device.In the alternative, the depression of a button on the communicationinterface activates the dispenser device. If the dispensing button ispressed, the defined loading dose (e.g., physician defined loading dose)is dispensed. The software may display “loading dose.” Once a successfuldispensing sequence has been completed by the device, it may report tothe third party host with an output noting “process complete” or“process incomplete” (in the event of an error). The patient takes theloading dose, a message is displayed to contact the physician, and nofurther doses are permitted until instructed by the physician. Thephysician is contacted, and a consult occurs, such as but not limited toa telephone consult, in which the physician determines the course ofmedicine to be dispensed. Simultaneously, no further doses arepermitted. The physician provides instructions to the third party host,namely, to the administration software. In the interim, the dispenserdevice may display “awaiting physician doses”, “awaiting next dose”, orthe like. Upon receipt of instructions, the software application sendsfull dosing instructions to the device for the full course, with one ormore times to dispense medication. The dispenser device then displaysthat the next dose is available. If the next dose is available, thesystem queries whether the dispense button has been depressed. If thebutton is depressed, then the dispenser device is operated to deliver ordispense x-number of pills or a predetermined quantity of medication andthe amount is displayed on the device screen. If the dispense button hasnot been depressed at the time the next dose is available, then thesystem queries whether the current time is greater than a first presetdispensing time (for example, time “t”+30 minutes). If this parameterhas not been met, then the next dose remains available and this messagecontinues to be displayed for the patient. If the current time hasexceeded the first preset dispensing time, a message is displayed to thepatient that a dose is overdue. In one or more examples of embodiment,the software may deliver periodic push notifications to the user untilit receives a message from the dispenser that the does has beendelivered. The system then queries whether the current time is greaterthan a second preset dispensing time (for example, time “t”+2 hours). Ifthis parameter has not been met, the system cycles to query whether thepatient has pressed the dispense button again, and subsequently thefirst preset dispensing time. If the second preset dispensing time hasbeen exceeded, the system alerts the physician and, again, cycles toquery whether the patient has pressed the dispense button. If thepatient presses the dispense button and medicine is dispensed, then thesystem queries whether the last prescribed dose has been dispensed. Ifnot, the system cycles to await the next dose. If the last prescribeddose has been dispensed, then instructions are sent to the device todispense a loading dose upon request. The dispenser device holds greaterthan or equal to the defined minimum amount of medication (e.g., numberof pills or tablets) for the next course. This defined minimum may beset, for example, by the physician via the third party host. If thisparameter is met, the first dose is then made available and cyclerepeats. If the minimum is not met the dispenser device alerts thephysician—through the third party host, of a need for a refill or a newdevice.

Accordingly, the foregoing describes an automated medication dispensersystem. The automated medication dispenser system generally includes adispenser device comprising a medication dispensing and storage module,a dispensing drive and control mechanism, and a communicationsinterface. The communications interface may include a screen and one ormore control buttons. The system also includes a third partycommunications host in communication with the dispenser device, and hasadministration software with executable instructions for control of thedispensing drive and control mechanism to dispense medication from themedication dispensing and storage module. The executable instructionsmay include dose quantity and dose time. The communications interface isin communication with the third party communications host. In one ormore examples of embodiments, the dispenser device may also compriselocalized control software required to perform independent dispensingoperations. In one or more examples of embodiments, the dispenser devicemay also include a gyroscope and accelerometer for monitoring anorientation of the dispenser device.

One or more examples of operation of the dispenser device 100 will nowbe described in reference to the Figures for purposes of illustration.

The dispenser device 100 is pre-loaded and sealed with a pre-determinedamount of medicine 120. Once the device has been loaded and deployed toa user, it is turned on via the discrete momentary contact 154. Thisprovides power to the microprocessor 104 from, for example, the onboardrechargeable battery pack 128. The device may be powered up at all timesand remain powered up indefinitely. Alternatively, the device may bepowered “on-call.”

Upon powering on the device, a series of startup messages may bedisplayed via the LCD screen 148. The microprocessor 104 is initializedand the device 100 pairs with its third party host. If pairing for thefirst time, messages may be provided to guide the user through theinitial setup. Once successfully paired, the device receives its initialdispensing data. As indicated, the initial dispensing data is providedas a data packet which may consist of integers that populatepreconfigured set point fields and form the basis of the dispensingcriteria. The dispensing criteria may contain the number of cyclesrequired per dispensing event, as well as the number of times an eventcan be executed.

The execution of each dispensing event is also controlled by the datapacket. In one or more examples of embodiments, the number of eventsdeployable within a given time frame is controlled. The total number ofdispensing events allowable between reloading of the data from the thirdparty host may also be controlled. If the device is not paired with thehost, a total number of events may be allowed or limited in keeping withthe pre-loaded criteria.

Once the total number of dispensing events has been deployed, the devicewill await instruction from the third party host. If pairing is notre-established and a new data packet uploaded, the device may enter alow power hibernation mode until re-paired or until, for example, thebattery is depleted. To this end, charging and/or recharging of thedevice may maintain the hibernation mode indefinitely.

As indicated, the dispenser device 100 contains an electronicaccelerometer 156 and 3-axis gyroscope 158. Accordingly, the device'saxial position and its state of rest are constantly monitored,regardless of its power state. For example, the accelerometer 156 maysense motion and alert the microprocessor 104 to enter the “Power On”mode (if not already transferred into this mode). In one or moreexamples of embodiments, in order to actuate a dispense cycle, thedevice must be in the “Power On” mode. The gyroscope 158 senses theaxial position of the dispenser device 100 relative to its environment.In one or more preferred examples of embodiments, in order for thedevice to be able to successfully dispense, the device 100 must beinverted so as to align the dispensing housing's main axis in a verticalposition. In this position, not only is the main axis (x′) verticallypositioned, but the face containing the LCD screen 148 and interfacebuttons are facing up (see FIG. 7 ). The gyroscope 158 confirms thisalignment and may inhibit any actuation (and thus medicine dispensing)until correct alignment is achieved. Once oriented correctly and thepower status is in the “Power On” mode, the device is available fordispensing.

Depressing a button 152 on the control interface 146 may commence adispensing sequence in keeping with the data stored on the device atthat time. Once a dispensing sequence is received, the microprocessor104 determines how many cycles are to be dispensed. The microprocessor104 enables the DC gear motor 106 to start operation. The motor 106actuates, rotating pinion gear 110 which, in turn, rotates internal gear112 and the dispensing plate 114. The holes in the dispensing plate 114momentarily align with cavities in the pill holder 118 as the dispensingplate 114 rotates. As indicated, pill silos 122 are arranged in acircular configuration about the dispenser plate's axis of rotation.

Spring pressure, from the compression spring and spring seat 124 locatedat the base of each pill silo 122, is exerted on the base of each pillsilo 122 forcing an entire column of pills 120 in the pill silo 122 inthe direction of the dispensing plate 114. Rotation of the dispensingplate 114 aligns the plate's aperture or cavity with a pill silo 122,and spring force (assisted by gravity) inserts a pill into a vacantaperture in the dispensing plate 114. Once the aperture or cavity ispopulated, the resident pill inhibits additional silos 122 from loadinginto that particular aperture or cavity as the populated cavity isrotated about the respective silos 122.

The populated aperture or cavity continues to rotate until it alignswith a hole located in the motor mounting flange 108. Referring to FIGS.10-12 , during the rotation, the cycle count switch is depressed by acam (i.e., the cycle count cam lobe 144) located on the dispensing plateeach time a cavity passes the unloading point. The cam 144 is positionedto coincide with each hole or aperture of the dispensing plate as itarrives at the unloading point. The cycle count switch 160 is depressedonce every time a cam lobe (and coinciding cavity) passes by, thusproviding a cycle count to the microprocessor during actuation. Gravity,assisted by the hole's geometry, allows the pill to fall freely throughthe motor mounting flange 108 and continue through a feed chute 130located in the battery housing 126, finally passing through theretaining plate 132 and coming to rest in the chamber located betweenthe retaining plate 132 and the dispenser cap 136. The cycle count camlobe 144 further assists the evacuation of the pill through the motormounting flange 108 as it passes through the center of the cavity duringthe rotation cycle. The dispenser cap 136 may then be removed toretrieve the dispensed pill 120.

One or more specific examples of use of the dispenser 100 will now bedescribed for purposes of illustration. One of skill in the art wouldunderstand that variations thereon would be acceptable without departingfrom the overall scope of the present invention.

The patient stores the dispenser device 100 in a location in keepingwith their needs. In the event that the patient needs to accessmedication, the patient begins retrieving the device, inverting it toorient the dispenser 100 in a vertical plane with the LCD screen 148facing up (FIG. 7 ). If the device is not in the “Power On” mode(signified by an on screen message on the LCD screen 148), the patienthas the option of either lightly moving the device to awaken it orpressing an activation button 154 or the sleep button 150 momentarily.

Once the device is in “Power On” mode, the patient can depress an“actuate” or “dispense” button 152. The device 100 will then actuate anddispense the quantity of medicine as set forth in the data packet. TheLCD screen 148 may display a message, such as the message “Dispensing,”while in operation. Once dispensing is complete the LCD screen 148 may,likewise display a message, such as, but not limited to “Dose Available”or the like. The patient can now retrieve the dose by opening thedispenser cap 136.

Accordingly, the foregoing describes a method for control and monitoringthe dosing of medication. The method generally includes connecting adispenser device with a third party host, and once paired, automaticallycommunicating the availability of a dose of medication to the dispenserdevice. Depression of a button on a communication interface may activatethe dispenser device, or upon lifting of the dispenser device, anaccelerometer activates the dispenser device. Following loading of thedose of medication, the loading of additional doses of medication may berestricted without additional dosing instructions. Dosing instructionsare communicated with the involvement of the third party host. Forexample, request for further dosing instructions is communicated to athird party host. Upon receipt of dosing instructions from the thirdparty host, dosing instructions are sent to the dispenser device.Dispensing of medication from the device may occur, in one or moreexamples of embodiments, only when the dispense button is depressed.Accordingly, the process further includes querying whether a dispensebutton has been depressed and operating the dispenser device to delivera predetermined quantity of medication according to the dosinginstructions, as well as counting the dispensation of the medication.The method also may comprise the step of simultaneously displaying amessage on a communication interface of the dispensing device. A currenttime may be queried relative to one or more preset dispensing times.Additionally, the method may include sending an alert to a third partyhost.

The dispenser device described herein provides various advantages ofexisting methods of identification and treatment, as well as control ofmedication dosing and use. A mechanism to monitor and control of thedispensation of medication is also provided. Moreover, the dispensingdevice having the features described herein provides improved means todetermine and use pharmacy data on the use of medication, such as oralsteroids. In addition, the device allows for additional interventionsthat would further reduce the patent's risk for further exacerbations.

While the device is described herein for use with the dispensation ofpills, and in one or more examples of embodiments in reference to theassessment of oral corticosteroid use associated with asthma, theinvention is not limited thereto. One of skill in the art wouldunderstand that the use in association with OCS use for asthma is merelyone of many examples by which a physician, pharmacist, insurancecompany, patient, and others may monitor, control, and dispensemedication. Likewise, one of skill in the art would appreciate thealternative forms of medication apart from pills may be used with theinventions described herein.

As utilized herein, the terms “approximately,” “about,” “substantially,”and similar terms are intended to have a broad meaning in harmony withthe common and accepted usage by those of ordinary skill in the art towhich the subject matter of this disclosure pertains. It should beunderstood by those of skill in the art who review this disclosure thatthese terms are intended to allow a description of certain featuresdescribed and claimed without restricting the scope of these features tothe precise numerical ranges provided. Accordingly, these terms shouldbe interpreted as indicating that insubstantial or inconsequentialmodifications or alterations of the subject matter described and claimedare considered to be within the scope of the invention as recited in theappended claims.

It should be noted that references to relative positions (e.g., “top”and “bottom”) in this description are merely used to identify variouselements as are oriented in the Figures. It should be recognized thatthe orientation of particular components may vary greatly depending onthe application in which they are used.

For the purpose of this disclosure, the term “coupled” means the joiningof two members directly or indirectly to one another. Such joining maybe stationary in nature or moveable in nature. Such joining may beachieved with the two members or the two members and any additionalintermediate members being integrally formed as a single unitary bodywith one another or with the two members or the two members and anyadditional intermediate members being attached to one another. Suchjoining may be permanent in nature or may be removable or releasable innature.

It is also important to note that the construction and arrangement ofthe system, methods, and devices as shown in the various examples ofembodiments is illustrative only. Although only a few embodiments havebeen described in detail in this disclosure, those skilled in the artwho review this disclosure will readily appreciate that manymodifications are possible (e.g., variations in sizes, dimensions,structures, shapes and proportions of the various elements, values ofparameters, mounting arrangements, use of materials, colors,orientations, etc.) without materially departing from the novelteachings and advantages of the subject matter recited. For example,elements shown as integrally formed may be constructed of multiple partsand vice versa, the operation of the interfaces may be reversed orotherwise varied, the length or width of the structures and/or membersor connectors or other elements of the system may be varied, the natureor number of adjustment positions provided between the elements may bevaried (e.g., by variations in the number of engagement slots or size ofthe engagement slots or type of engagement). The order or sequence ofany process or method steps may be varied or re-sequenced according toalternative embodiments. Other substitutions, modifications, changes andomissions may be made in the design, operating conditions andarrangement of the various examples of embodiments without departingfrom the spirit or scope of the present inventions.

While this invention has been described in conjunction with the examplesof embodiments outlined above, various alternatives, modifications,variations, improvements and/or substantial equivalents, whether knownor that are or may be presently foreseen, may become apparent to thosehaving at least ordinary skill in the art. Accordingly, the examples ofembodiments of the invention, as set forth above, are intended to beillustrative, not limiting. Various changes may be made withoutdeparting from the spirit or scope of the invention. Therefore, theinvention is intended to embrace all known or earlier developedalternatives, modifications, variations, improvements and/or substantialequivalents.

The technical effects and technical problems in the specification areexemplary and are not limiting. It should be noted that the embodimentsdescribed in the specification may have other technical effects and cansolve other technical problems.

1. An automated medication dispenser system comprising: a dispenserdevice comprising a medication dispensing and storage module, adispensing drive and control mechanism, and a communications interface;and a third party communications host in communication with thedispenser device, and having administration software with executableinstructions for control of the dispensing drive and control mechanismto dispense medication from the medication dispensing and storagemodule, wherein the communications interface is in communication withthe third party communications host.
 2. The automated medicationdispenser of claim 1, wherein the dispenser device comprises localizedcontrol software required to perform independent dispensing operations.3. The automated medication dispenser system of claim 1, wherein thecommunication interface comprises a screen and one or more controlbuttons.
 4. The automated medication dispenser system of claim 1,wherein the dispenser device comprises a gyroscope and accelerometer formonitoring an orientation of the dispenser device.
 5. The automatedmedication dispenser system of claim 1, wherein the executableinstructions include dose quantity and dose time.
 6. A medicationdispenser comprising: a dispenser housing containing: a microprocessorwhich is linked to a gear motor, wherein the gear motor is coupled to apinion gear, and the pinion gear is engaged with an internal gear; amedication dispensing plate coupled to the internal gear, wherein as thegear motor actuates, the pinion gear rotates which rotates internal gearand the dispensing plate; and a stationary medication holder, withmedication stores arranged in a circular configuration about thedispensing plate's axis of rotation; wherein spring pressure is exertedon a base of each medication store forcing medication therein in thedirection of the dispensing plate, such that a dose of medication isforced into a vacant aperture in the dispensing plate.
 7. The medicationdispenser of claim 6, wherein the stationary medication holder containsa pre-loaded quantity of medication.
 8. The medication dispenser ofclaim 7, wherein the medication is one or more pills stored in one ormore silo configurations.
 9. The medication dispenser of claim 6,further comprising a battery cell within the dispenser housing.
 10. Themedication dispenser of claim 6, wherein a longitudinal cavity extendsfrom the medication holder to a delivery end of the medication dispenserfor passage of medication.
 11. The medication dispenser of claim 6,further comprising a dispenser cap coupled to the dispenser housing. 12.The medication dispenser of claim 6, wherein the dispensing platecontains a series of apertures that, when the dispensing plate rotates,momentarily align with medication stores in the medication holder and acam lobe for use in counting dispensation of medication.
 13. Themedication dispenser of claim 6, wherein the dispenser housing has acommunications interface.
 14. The medication dispenser of claim 6,wherein the microprocessor has a wireless communications module.
 15. Themethod of claim 6, wherein the dispenser device has an accelerometerwhich activates the dispenser device.
 16. A method for control andmonitoring the dosing of medication comprising: connecting a dispenserdevice with a third party host; once paired, automatically communicatingthe availability of a dose of medication to the dispenser device;following loading of the dose of medication, restricting the loading ofadditional doses of medication without additional dosing instructions;communicating dosing instructions with the third party host; uponreceipt of dosing instructions, sending the dosing instructions to thedispenser device; and querying whether a dispense button has beendepressed and operating the dispenser device to deliver a predeterminedquantity of medication according to the dosing instructions and countingdelivery of the predetermined quantity of medication.
 17. The method ofclaim 16, wherein the method comprises the step of simultaneouslydisplaying a message on a communication interface of the dispensingdevice.
 18. The method of claim 16, wherein medication is dispensed onlywhen a dispense button on the dispenser device is depressed.
 19. Themethod of claim 16, further comprising querying a current time relativeto one or more preset dispensing times
 20. The method of claim 16,further comprising sending an alert to a third party host.